STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients With Recurrent Grade 3 Astrocytoma.
Document Type
Article
Publication Title
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Abstract
PURPOSE: STELLAR (ClinicalTrials.gov identifier: NCT02796261) was a phase III, randomized, open-label trial of eflornithine + lomustine versus lomustine monotherapy in patients with recurrent grade 3 astrocytoma.
METHODS: At trial initiation, eligibility criteria included: age ≥18 years, anaplastic astrocytoma (2016 WHO CNS Tumor classification [WHO CNS4]), first recurrence ≥6 months after radiation and temozolomide (TMZ), Karnofsky performance status ≥70, and no imaging findings consistent with grade 4 glioblastoma. Random assignment (1:1) was stratified by
RESULTS: Among 343 patients randomly assigned across 74 sites in eight countries, there was no difference in survival between eflornithine + lomustine and lomustine monotherapy (median OS 23.4
CONCLUSION: Clinically meaningful improvements were observed; eflornithine + lomustine doubled PFS and improved OS in patients with recurrent
First Page
2501204
Last Page
2501204
DOI
10.1200/JCO-25-01204
Publication Date
12-1-2025
Recommended Citation
Colman H, Lombardi G, Wong ET, Walbert T, Eoli M, Lassman AB, Peereboom DM, Kizilbash SH, Kamiya-Matsuoka C, Pitz MW, Strowd RE, Desjardins A, Kumthekar P, Mason W, Pellerino A, Soffietti R, Butowski N, Forsyth PA, Hamza MA, Hau P, Lallana E, Nabors B, Piccioni D, Uhlmann EJ, Welsh LC, Wen PY, Dietrich J, Wang C, Levin VA. STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients With Recurrent Grade 3 Astrocytoma. J Clin Oncol. 2025 Dec 1:JCO2501204. doi: 10.1200/JCO-25-01204. Epub ahead of print. PMID: 41325560.